YY/T 0466.1-2016 in English

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: general requirements

1 Scope

This part of YY/T 0466 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this part of YY/T 0466.

This part is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.

These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this part are not intended to apply to symbols specified in other standards.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 7000 Graphical symbols for use on equipment - Index and synopsis
ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times
ISO 14971 Medical devices - Application of risk management to medical devices
ISO 15223-2 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2: Symbol development, selection and validation

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 14971 and the following apply.

3.1
characteristic information
information that represents the property or properties of a symbol
 
3.2
description
normative text which defines the purpose, application and use of the symbol

Note: Adapted from GB/T 23371.1-2013, definition 3.2.

3.3
label
written, printed or graphic information provided upon the medical device itself

Note: Adapted from GHTF/SG1/N43:2005.

3.4
labelling
information supplied by the manufacturer that is provided for, associated with, or affixed to, a medical device or any of its containers or wrappers

Note 1: This information relates to the identification, technical description and use of the medical device, but excludes shipping documents.

Note 2: Some regional and national regulations refer to “labelling” as “information supplied by the manufacturer”.

3.5
symbol used in medical device labelling
graphical representation appearing on the label and/or associated documentation of a medical device that communicates characteristic information without the need for the supplier or receiver of the information to have knowledge of the language of a particular nation or people

Note: The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar objects, including alphanumeric characters.

Foreword II
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Proposal of symbols for adoption
4.2 Requirements for usage
4.3 Other symbols
5 Symbols
5.1 Manufacture
5.2 Sterility
5.3 Storage
5.4 Safe use
5.5 IVD-specific
5.6 Transfusion/infusion
5.7 Other
Annex A (Informative) Examples
Annex B (Informative) Use of general prohibition symbol and negation symbol
Bibliography